President of India Launches India’s First home-produced Gene Therapy for Cancer

What Is NexCAR19 and How Does It Work?

NexCAR19 is India’s first indigenously developed CAR T-cell therapy for the treatment of blood cancers, including leukemia and lymphoma. It involves genetically modifying a patient’s immune cells to express a chimeric antigen receptor (CAR) that specifically targets and destroys cancer cells expressing the CD19 antigen, which is commonly found on B-cell malignancies.

The process involves extracting T cells from the patient’s blood, genetically engineering them in a laboratory to express the CAR, and then infusing the modified cells back into the patient. The CAR T cells then seek out and eliminate cancer cells, providing a targeted and potentially long-lasting treatment.

India’s first CAR-T cell therapy is developed through collaboration between the Indian Institute of Technology, Bombay and Tata Memorial Hospital in association with industry partner ImmunoACT. It is the world’s most affordable CAR-T cell therapy.

What Are the Advantages of NexCAR19 Over Existing Cancer Treatments?

NexCAR19 offers several advantages over conventional cancer treatments like chemotherapy and radiation therapy:

• Targeted therapy: CAR T cells specifically target cancer cells expressing the CD19 antigen, minimizing damage to healthy cells.
• Potential for long-term remission: CAR T cells can persist in the body for years, providing ongoing surveillance against cancer recurrence.
• Reduced side effects: Compared to chemotherapy and radiation, CAR T-cell therapy has fewer systemic side effects.
• Cost-effective: NexCAR19 is priced at around ₹30-40 lakh ($37,500-50,000 USD) per patient, which is significantly lower than the cost of similar therapies abroad, which can range from ₹3-4 crore ($375,000-500,000 USD).

What Is the Current Status of NexCAR19 in India?

NexCAR19 received market authorization from the Central Drugs Standard Control Organisation (CDSCO) in October 2023, paving the way for its commercial use in India.

In January 2024, Kokilaben Dhirubhai Ambani Hospital in Mumbai started to offer NexCAR19 to cancer patients. The therapy is expected to be available at more than 30 hospitals across 10 cities in India, making it accessible to a larger patient population.

What Are the Challenges in Making Gene Therapies Like NexCAR19 Widely Accessible?

Despite the potential of gene therapies like NexCAR19, several challenges need to be addressed to make them widely accessible:

• High cost: Even at a reduced price, NexCAR19 may still be unaffordable for many patients in India.
• Limited manufacturing capacity: The complex manufacturing process for CAR T cells requires specialized facilities and skilled personnel, limiting the scale of production.
• Regulatory hurdles: Obtaining regulatory approvals for gene therapies can be a lengthy and expensive process, delaying their availability.
• Lack of awareness: There is a need for greater awareness among patients and healthcare providers about the potential of gene therapies.

The Department of Biotechnology (DBT) has established the National Biopharma Mission to promote the development of affordable biopharmaceuticals, including gene therapies.

What Is the Current State of Cancer Treatment in India?

According to the latest estimates from the National Cancer Registry Programme (NCRP) Report Published in March 2023, India reported a staggering 1,461,427 new cancer cases in 2022.

This means that approximately one out of every nine Indians is expected to be diagnosed with cancer at some point in their life (between the ages of 0 and 74).

The most common types of cancer differed between genders, with lung cancer being the leading site among males and breast cancer being the most prevalent among females.When it comes to childhood cancers (ages 0-14), lymphoid leukemia was found to be the most common, accounting for 29.2% of cases in boys and 24.2% in girls.

Unfortunately, the cancer burden in India is projected to worsen in the coming years, with estimates from the NCRP Report 2020 suggesting a 12.8% increase in cancer incidence by 2025 compared to the figures from 2020.

How Does NexCAR19 Compare to Other Global CAR T-Cell Therapies?

NexCAR19 is comparable to other globally approved CAR T-cell therapies in terms of its efficacy and safety profile.

The key advantage of NexCAR19 is its significantly lower cost, which is around one-tenth of the price of similar therapies in developed countries.

The humanised design of NexCAR19 also sets it apart from some other CAR T-cell therapies, potentially reducing the risk of immune-related side effects.

What Are the Side Effects and Safety Concerns of CAR T-Cell Therapies?

CAR T-cell therapies can cause several side effects, the most common being cytokine release syndrome (CRS) and neurotoxicity:

• CRS occurs when the immune system is highly activated, leading to symptoms like fever, hypotension, and respiratory distress.
• Neurotoxicity can manifest as confusion, seizures, or cerebral oedema.

These side effects are usually manageable with supportive care and immunosuppressive medications. Long-term safety data on CAR T-cell therapies is still limited, and patients require close monitoring and follow-up.

What Are the Challenges and Future Prospects for Gene Therapies in India?

Despite the promising results of NexCAR19, there are several challenges in implementing gene therapies widely in India. These include the need for specialised infrastructure, trained personnel, and robust regulatory frameworks. The high cost of gene therapies, even with the reduced pricing of NexCAR19, is still be a barrier for many patients.

Future research and development efforts should focus on:

• Further optimising the manufacturing process
• Exploring new targets and indications for CAR T-cell therapy
• Developing innovative financing models to ensure equitable access to these advanced treatments

With continued investment in research, infrastructure, and capacity building, India has the potential to save the lives of millions of patients in the country and beyond.